Sunitinib and Atrial Trabeculae Contractility
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Radboud University
临床试验: NCT01246778
BioSeek: nct01246778
关键词
抽象
Rationale:
Recently, sunitinib (a tyrosine kinase inhibitor that is used for treatment of metastatic renal carcinoma and gastrointestinal stroma tumors) has been associated with development of heart failure, possibly by off-target inhibition of AMP-protein kinase. The investigators hypothesize that sunitinib reduces the contractile ability of myocardium and the tolerance against ischemia-reperfusion and that activators of AMP-protein kinase such as atorvastatin and AICAR reverse this unwanted effect of sunitinib.
Objectives:
The primary objective of the study is to investigate the effect of sunitinib on ex-vivo atrial contractile force in absence and presence of ischemia-reperfusion.
A secondary objective is to explore if atorvastatin or AICAR prevent sunitinib-induced deterioration of contractile function of human atrial trabeculas. Study design: Lab
描述
Study population: 44 (+22) patients undergoing CABG cardiac surgery with extracorporal circulation Intervention (if applicable): none (pharmacological interventions will only be performed ex-vivo in isolated atrial tissue) Main study parameters/endpoints The developed force in ex vivo atrial trabeculas during standardized stimulation.
日期
| 最后验证: | 03/31/2014 |
| 首次提交: | 11/21/2010 |
| 提交的预估入学人数: | 11/21/2010 |
| 首次发布: | 11/22/2010 |
| 上次提交的更新: | 04/29/2014 |
| 最近更新发布: | 04/30/2014 |
| 实际学习开始日期: | 10/31/2010 |
| 预计主要完成日期: | 03/31/2014 |
| 预计完成日期: | 03/31/2014 |
状况或疾病
Cardiotoxicity
Ischemia
Heart Failure
相
-
手臂组
| 臂 | 干预/治疗 |
|---|---|
| With/without sunitinib Two trabeculas will be isolated and one will be exposed to sunitinib and the other to normal buffer solution. Both will be stimulated to contraction during 200 minutes. | |
| With/without sunitinib IP Two trabeculas will be isolated and one will be exposed to sunitinib and the other to normal buffer solution. Both will be stimulated to contraction and ischemia/reperfusion |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 取样方式 | Non-Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Cardiac surgery with extracorporal circulation Exclusion Criteria: - Use of oral antiarrhythmics - theophylline use - Use of sulfonylureas - Atrial arrythmias - Right ventricular failure |
结果
主要结果指标
1. Force [200 minutes]
The developed force in ex vivo atrial trabeculae during standardized stimulation.
次要成果指标
1. Speed [200 minutes]
The difference in averaged maximal speed of tension reduction during relaxation between two trabeculae
2. Maximal Speed [210 minutes]
The difference in averaged maximal speed of tension development during contraction between two trabeculae.
